ATTUNE 1518-10-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10603295056645), received between Jan 4, 2018 and Aug 12, 2026 — classified as 113 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50224690 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to ligamentous instability and loosening of the tibia at the cement to implant interface. DePuy cement was used.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50131632 ↗
• MalfunctionMay 13, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE SEALED/WRAPPED BOX. THE OUTER PLASTIC WRAP WAS ALSO INTACT. DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163646 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT FOR INFECTION. IMPLANTS DID NOT FAIL. NO LOOSENING. NO INSTABILITY. NO DELAY. NO OTHER INFO KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE:

  Patient problems: Unspecified Infection

  MAUDE report 24926352 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530553 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY WITH DOWNSIZING OF THE FEMUR COMPONENT AND REVISION OF THE TIBIAL INSERT AND PATELLA COMPONENTS. THE PATIENT DEVELOPED ARTHROFIBROSIS, RESULTING IN KNEE STIFFNESS AND IMPAIRED JOINT MOVEMENT, WHICH LED TO AN INABILITY TO ADEQUATELY EXTEND OR FLEX THE KNEE. DOI-(B)(6) 2023, DOR-(B)(6) 2026, AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 24507007 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR FRACTURE OF PATELLA DUE TO FALL. NO FURTHER INFO AVAILABLE. DOI- (B)(6) 2021, DOR- (B)(6) 2026, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24421486 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LIMITED RANGE OF MOTION; SURGEON OPTED TO CHANGE POLY AND PATELLA TO INCREASE ROM. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 24214808 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE OCCURRED DUE TO INFECTION. ORIGINAL SURGERY WAS DONE ABOUT TWO YEARS AGO. EXACT DATE UNKNOWN. RIGHT SIDE. COMPONENTS WERE WELL FIXED. ALL COMPONENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 24166854 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY AND PATELLA TRACKING ISSUES DUE TO TIBIAL AND FEMORAL ALIGNMENT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23577663 ↗
• InjuryNov 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE DUE TO INFECTION. PATELLA WAS LOOSE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23569499 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22689406 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR PLANNED TO DO A QUADRICEPS TENDON REPAIR. DURING THE PROCEDURE THE PATELLA WOULD NOT REDUCE. AFTER MULTIPLE TRIES AND RELEASES, DOCTOR CLOSED WITHOUT A PATELLA AND REPLACED THE POLY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22569000 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND KNOCKED THE PATELLAR COMPONENT LOOSE. THERE WAS PATELLA LOOSENING AT BONE CEMENT INTERFACE ALSO DISRUPTED THE QUAD TENDON. A COMPETITOR'S CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain; Unspecified Tissue Injury

  MAUDE report 22140293 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6), 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105546 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH BILATERAL RESECTIONS DUE TO INFECTIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21619472 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH BILATERAL RESECTIONS DUE TO INFECTIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21619263 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21513509 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN. FULL REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21170962 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Pain

  MAUDE report 20853129 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 10 APR 2019. DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION

  Patient problems: Adhesion(s)

  MAUDE report 20471425 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 22 NOV 2018 DATE OF IMPLANT: (B)(6) 2018 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461672 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED AND PLACED ABX SPACER FOR INFECTION. NO BROKEN PARTS. ALL PIECES RETRIEVED. NO CASE DELAY. NO COMPLAINTS. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20290470 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A LONG HISTORY OF INFECTION. FEMUR, TIBIA, TIBIA POLY INSERT AND PATELLA WERE REMOVED BECAUSE OF INFECTION. TIBIA POLY WAS EXCHANGES ON (B)(6) 2023 BECAUSE OF INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19782172 ↗
• InjuryMay 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISE DUE TO AESEPTIC LOOSENING OF THE PATELLA, TIBIA AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. FULL ATTUNE CRS WAS RE-IMPLANTED, THERE WAS NO X-RAYS AVAILABLE AT THIS TIME, IMPLANTS NOT BEING RETURNED. DOI: (B)(6) 2019. DOR: (B)(6) 2024/ AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19219916 ↗